May 16, 2011

AMA CEJA 2011: Financial Relationships with Industry in Continuing Medical Education Version 5.0 – Better But Not There Yet?

The American Medical Association (AMA) Council on Ethical and Judicial Affairs recently released Report 1-A-11 entitled, “Financial Relationships with Industry in Continuing Medical Education.” This is CEJA’s fifth attempt to ask individual physicians and institutions of medicine to not accept industry funding to support professional educational activities. As we previously noted, the 2010 CEJA report was the same as the 2009 report, both of which were referred back to committee and voted down by the AMA House of Delegates. While the 2011 Report and its recommendations have made improvements from its predecessors, the reasoning and rationale behind this report are still problematic.

Background

In this year’s report, as in others, CEJA explicitly recognizes that, “relationships between medicine and industry—such as pharmaceutical, biotechnology, and medical device companies—have driven innovation in patient care, contributed to the economic well-being of the community, and provided significant resources (financial and otherwise) for professional education, to the ultimate benefit of patients and the public.” Despite this recognition, CEJA asserts however that the “interests and obligations of medicine and industry diverge in important ways.”

Industry makes life saving and changing treatments, devices, and tools to help improve the health of people each day. Through commercial research, development and discovery, companies are finding ways to diagnose, treat and prevent serious, chronic, and rare diseases at a faster rate than ever before. How such an obligation diverges from that of medicine is unapparent, especially considering doctors are obligated to use the treatments and tools industry provides to them to improve the health of patients.

Moreover, CEJA recognizes that, “industry support helps to meet the costs of CME activities in the face of uncertain funding from other sources and may help make CME more accessible, especially for physicians in resource-poor communities.” The report also points out that, “industry engagement and support can be especially helpful in ensuring affordable CME when educational activities need high cost, sophisticated, rapidly evolving technology or devices.” In addition to “lower costs, industry support also encourages greater participation than would otherwise be the case by providing amenities.”

Based on these comments, CEJA clearly understands that commercial support of CME has demonstrable benefits to physicians and patients, and there is evidence to prove this. For example, physicians who attended an industry-supported educational activity were 50% more likely to provide evidence-based care for COPD than nonparticipants. Another program showed that the patients of physicians who attended the industry supported educational activity were 52% more likely to receive evidence-based care than those seen by health care providers who did not participate in the activity. Commercially supported CME has also improved patient outcomes in intensive care units at hospitals and has helped patients with sepsis. Industry supported CME programs also help physicians fight hospital acquired infections.

In addition, the results of a recent study showed that “heart disease patients whose general practitioners participated in an interactive, case-based CME program had a significantly reduced risk of death over 10 years compared with those whose doctors didn't receive the education.”

Despite this evidence and CEJA acknowledging the critical role commercial support plays in CME, the report focuses their “growing concern” for industry funding on the “potential for bias.” Specifically, the report asserts that, “where patients’ health and public trust are concerned, the perception of bias, even if mistaken, can be as potentially damaging as the existence of actual bias.” This statement is extremely problematic for a number of reasons.

First, while CEJA asserts that the “perception of bias” can be as potentially damaging as the existence of actual bias, there is no evidence to support this claim. Moreover, how can anyone identify perceived bias? Evidence from three large studies shows there is almost no bias in commercially supported CME (Cleveland Clinic; Medscape, and UCSF). In fact, CEJA explicitly admits that, “the available data neither support nor disprove that financial relationships influence CME.”

Second, CEJA believes that even a “mistaken” perception of bias can be as damaging as actual bias. Such an assertion is extremely misguided. If a patient or physician is mistaken about a perceived bias, how can this be damaging? The real damage would be to remove a commercially supported CME program that helps improve patient outcomes because someone mistakenly believed there as potential or perceived bias.

Recommendations

Consequently, although using questionable methodology, reasoning, and research, CEJA made a number of recommendations to change the landscape of commercially supported CME. The first recommendation that CEJA proposes is that, “when possible, CME should be provided without such support or the participation of individuals who have financial interest in the educational subject matter.”

When is it possible for CME to be provided without commercial support? Today, and in the near future, America will demand more doctors. We have already seen a severe shortage of primary care doctors, particularly in rural and inner city areas. These problems will only continue to grow as provisions of the Affordable Care Act are implemented and bring an additional 30 million Americans into the health care system.

This all means that we will not only need more doctors, but more CME to keep our doctors up to date on ways to treat, diagnose, and prevent chronic disease and illnesses. Accordingly, we will need resources to provide CME to this expanded group of physicians. The government largely does not fund any kind of CME or programs, and the rest is left to commercial support or doctors/organization fees.

Moreover, a recent study found that Decreased Funding Has Significantly Affected Management of Grand Rounds, Extended CME Events, and Other Educational and Social Functions in Academic Departments. Because of decreased support, many academic CME departments reported that they engage fewer nationally-renowned, out-of-the-geographic-area speakers for Grand Rounds and CME conferences. Departments have less or no support for meals associated with Grand Rounds and other departmental functions and have less discretionary support for varied conference expenses.

Next, CEJA recognized that in some circumstances, support from industry or participation by individuals who have financial interest in the subject matter may be needed to enable access to appropriate high-quality CME. As a result, they recommend that vigorous efforts be made to maintain the independence and integrity of educational activities. What is problematic about this recommendation is that CEJA recognizes that in many cases, “high-quality CME cannot reasonably be carried out without support from sources that have a direct financial interest in physicians’ clinical recommendations, such as activities that require cadavers or high-cost, or sophisticated equipment to train physicians in new procedures or the use of new technologies.”

If high-quality CME cannot reasonably be carried out without commercial support, why is CEJA telling stakeholders to do so, “whenever possible?” Isn’t that a huge risk to take, not accepting commercial support, but having a low-quality CME program? What will cause more harm: mistaken perceptions of bias, or CME that does not educate or train doctors effectively?

CEJA also acknowledges that, “in the earliest stage of adoption of a new medical device, technique, or technology, the only individuals truly qualified to train physicians in its use are often those who developed the innovation. These individuals may have the most substantial and direct interests at stake, whether through employment, royalties, equity interests or other direct financial interests in the adoption and dissemination of the new technology.” When numerous individuals can fall in this category, why is CEJA recommending rules that will only make it harder for these individuals to provide meaningful CME to their colleagues?

In addition, CEJA recommends that physicians who attend CME activities should expect that commercially supported CME:

Is transparent about financial relationships that could potentially influence educational activities

Provides the information physician-learners need to make critical judgments about an educational activity, including:

The source(s) and nature of commercial support for the activity; and/or

The source(s) and nature of any individual financial relationships with industry related to the subject matter of the activity; and

What steps have been taken to mitigate the potential influence of financial relationships

Adhering to a transparent process for prospectively determining when industry support is needed

Giving preference in selecting faculty or content developers to similarly qualified experts who do not have financial interest in the educational subject matter

Ensuring a transparent process for making decisions about participation by physicians who may have a financial interest in the educational subject matter

Permitting individuals who have a substantial financial interest in the educational subject matter to participate in CME only when their participation is central to the success of the educational activity; the activity meets a demonstrated need in the professional community; and the source, nature, and magnitude of the individual’s specific financial interest is disclosed

Taking steps to mitigate potential influence commensurate with the nature of the financial interest(s) at issue, such as prospective peer review.

The problem with the overwhelming majority of this last set of recommendations is that they are already incorporated into the CME community through the 2005 ACCME Standards for Commercial Support, so the need for these additional rules in not necessary. In addition to the regulations and changes noted above, CME stakeholders have also reduced and managed any potential for bias through:

The National Faculty Education Initiative, which trains CME faculty on the difference between certified CME content and presentations and promotional/other content

The ACCME requirement to both identify (via financial disclosures for all faculty and CME con­tent developers) conflicts and resolve them through mechanisms including elimination of the faculty member, altering the conflicted faculty member’s role, etc.

Monitoring and enforcement of Standards for Commercial Support for CME independence from promotional influence

The development of separate CME/IME departments within commercial interest organiza­tions, ensuring CME is managed outside of sales/marketing departments

One group of recommendations dealing with faculty is particularly troubling,

Giving preference in selecting faculty or content developers to similarly qualified experts who do not have financial interest in the educational subject matter.

This recommendation is troubling because it sets up a discrimination class i.e. somehow those work with industry are less knowledgeable and or ethical than those who do not. Since there is no evidence of undue bias in talks by experts with financial interest than those without then perhaps this recommendation should be dropped entirely.

Conclusion

While changes in CEJA’s 2011 report are somewhat reasonable with respect to transparency and disclosure, the overall approach of the report is still problematic. Although CEJA recognizes in multiple parts of the 2011 report that commercial support of CME is extremely valuable to physicians and patients, they contradict themselves by asking the CME community not to use commercial support “whenever possible.”

According to Thomas Stossel, MD, Director of Translational Medicine at Harvard, "this topic is not an "ethical or judicial," rather a practical one and the underlying principles of the repeated CEJA emanations derive from opinions, not fact or sound logic."

Besides shrinking budgets and already scarce resources, this recommendation is misguided, especially considering CEJA’s own recognition that no evidence shows that commercial support of CME introduces bias. It is also problematic because CEJA is more concerned about perceived bias, even when mistaken, then they are about producing CME programs that will improve patient outcomes.

As CEJA notes in their report, “competing interests are a fact of life for everyone, including but not limited to physicians.” Instead of taking the extreme approach of not using commercial support “whenever possible,” CEJA needs to follow their own rationale and recognize that there are many instances when use of commercial support and CME faculty that have proper relationships with industry are not only desirable, but also crucial for improving patient outcomes and physician training and education.

In the coming months, commercially supported CME may play a key role in the implementation of health care reform.

In just the area of Accountable Care Organizations (ACO’s), the government will require 64 quality measures for participating facilities. Commercially supported CME provides a unique media to train and educate America’s health care providers on strategies on how to implement and meet those measures.

Rather than focus on amorphous topics such as “perceived bias,” we should focus our efforts on educational programs that improve patient care. In the end, the only thing that should matter to everyone is improving patient care, a goal that CME providers and industry have shared since the beginning. Effective and accurate education is the key, not who financially supports the education.